Therapeutic and protective dental device useful as an intra-oral delivery system

ABSTRACT

A dental device has a U-shaped carrier with at least one channel for embracing an arch of teeth. The carrier has recessed insets in the channel. Discrete inserts carrying a beneficial agent can fit into the insets and release the agent gradually. When the device is used in a primarily therapeutic application, the inserts may be installed into all or less than all of the insets to form various insert patterns. Thus, different oral regions can be affected by different insert patterns. When the device is used as an athletic mouthguard, temporary blanks may be initially fitted in the insets, while a portion of the mouthguard is softened before an arch of teeth is pressed into the channel to make a custom impression. The inserts that are later installed in the insets possess different physical properties than the carrier and may be positioned and shaped to mechanically buffer teeth of the arch from mechanical shocks as well as release beneficial agents. The inserts may be replaced or refreshed to maintain the beneficial agent, which may be xylitol, remineralizing agents, moisturizing agents, desensitizing agents, flavoring agents, breath fresheners, chemical and biological indicators, nutraceuticals, antibiotics, probiotics, other medications and chemotherapeutics, or other agents.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to dental devices that are worn onan arch of teeth, and in particular, to devices that can deliver abeneficial agent to, and protect the teeth and soft tissues frommechanical, chemical and biologic injury.

[0003] 2. Description of Related Art

[0004] Mouthguards are typically made from plastics materials such as anethylene vinyl acetate copolymer (EVA). Other devices such asdentoalveolar trays, carriers and splints may be made of EVA or otherbiocompatible plastic material. There are several categories ofmouthguards: Mouthguards that are stock pre-molded products and made ina variety of sizes, home or self-moldable to suit the physicalcharacteristics of the user, or custom molded by a dentist or otherprofessional to suit the characteristics of the user. Regarding physicalprotection, stock mouthguards are typically the cheapest and leasteffective in use while the custom molded and shaped mouthguards are themost expensive and effective in their impact absorbent properties.

[0005] Athletes in many sports wear mouthguards for prolonged periods.It is common knowledge that when these athletes engage in strenuousphysical activity, they lose and must replace significant amounts offluids, nutrients and calories. In order to hydrate themselves, andreplenish their energy, athletes must drink large quantities of fluidsand eat foods that are very often cariogenic. These cariogenic fluidsand materials cover the teeth, and when a mouthguard is insertedafterwards, the teeth are acted upon by cariogenic bacteria in an idealenvironment, shielded from the buffering ability of saliva.

[0006] In athletes, factors that serve to diminish salivary flow aroundthe teeth include the general sympathetic tone of the nervous system,dehydration and shielding of the teeth by a mouthguard. Moreover, theelderly, patients suffering from a variety of autoimmune diseases,patients on a variety of medications and patients treated in the headregion with external beam radiation may also suffer from reducedsalivary flow. Whatever the cause, reduced salivary flow greatlyincreases the incidence of dental caries and periodontal disease.

[0007] U.S. Pat. No. 4,920,984 relates to a mouthguard material that maybe custom shaped or molded employing a teeth impression cast pressedagainst softened thermoplastic sheet material that increases inthickness from one end to the other.

[0008] Australian patent specification 633269 discloses a mouthguardmade from an EVA copolymer having a softening point higher than thenormal temperature of an oral cavity but lower than the highesttemperature that the oral cavity can endure so that the user may adaptthe mouthguard to fit the mouth by biting onto it after it has beenheated. The shaping procedure may be repeated if the shape orconfiguration of the teeth should change.

[0009] In FIG. 15 of U.S. Pat. No. 5,082,007 a gel or fluid capsule iscontained between the upper and lower portions of a mouthguard. Thenature of this gel is not described and appears to serve a mechanical,that is, a shock absorbing function.

[0010] It is not only known to employ materials enabling custom or selfshaping of mouthguards, it has been suggested that mouthguards use otheradditives in the material of construction to enhance the characteristicsof the material. For example, in U.S. Pat. No. 4,044,762 an athleticmouthguard is formed from a mixture of a plastic resin (e.g., anethylene vinyl acetate that can be heated and softened to form acustom-fitted impression) and a fluoride compound that protects thewearer's teeth. As an alternative, the reference suggests spraying orotherwise coating the surface of a mouthguard with a fluoride compound.This fluoride compound is gradually delivered while the mouthguard isworn.

[0011] In FIGS. 7 and 8 of U.S. Pat. No. 5,323,787 a medicated pad isadhesively secured on the occlusal surface of a mouthpiece to treat theteeth and gums. The pad is saturated with a medicating substance in anintermediate layer of absorbent polymeric or fabric material, and thatintermediate layer is overlaid with a non-porous outer layer. The padcan either be replaced or soaked to renew the medication. Specificmedications are not discussed, although for other embodiments themouthpiece is soaked in sterilizing (bactericides) and mouth-refreshingingredients such as flavorings of the type used in conventionalmouthwashes.

[0012] German patent specification 4011204 discloses a mouthguardmaterial consisting of an EVA copolymer material, polycaprolactone andcolorants and perfumes and PVA (polyvinyl acetate) to reduce thesoftening point of the resultant mouthguard for ease of manipulation andshaping.

[0013] In U.S. Pat. No. 5,395,392 an infant's pacifier has a perforatedmouth bulb containing an powder, syrup, or tablet with an agent such asmonoclonal antibodies, fluorides, sorbitol, or xylite (xylitol).

[0014] Xylitol is a naturally occurring sugar. It is a five-carbonpolyalcohol, pentitol, which is widely distributed in nature. Mostfruits, berries and plants contain xylitol. Xylitol is also anintermediate of mammalian carbohydrate metabolism. Our bodies produce upto 1 5 grams of xylitol from other food sources using established energypathways. Xylitol use is known to reduce tooth decay rates both inhigh-risk groups (high caries prevalence, poor nutrition, and poor oralhygiene) and in low risk groups (low caries incidence using all currentprevention recommendations). Sugar-free chewing gums and candies madewith xylitol as the principal sweetener have already received officialendorsements from numerous international dental associations. Studiesusing xylitol as either a sugar substitute or a small dietary additionhave demonstrated a dramatic reduction in new tooth decay, along witharrest and even some reversal of existing dental caries. Xylitolprovides additional protection that enhances all existing preventionmethods. This xylitol effect is long lasting and possibly permanent. Lowdecay rates persist even years after the trials have been completed.

[0015] For the anticariogenic activity of casein phosphopeptides, seeU.S. Pat. Nos. 5,015,628; 5,834,427 (method of preparing caseinphosphopeptides); and 5,981,475. For various remineralizingcompositions, see U.S. Pat. Nos. 4,348,381; 5,562,895; 5,895,641; and6,036,944.

[0016] For various mouthguards and similar dental devices, see U.S. Pat.Nos. 4,554,154 (plastic that is chewable or usable as dental flosscarries remineralizing, immunological, and anti-bacterial agents; e.g.sodium flouride, chlorhexidine and lysozyme); 5,085,585 (U-shapedapplicator is placed over teeth to apply medicaments to teeth and gumpockets); 5,194,003 (device that fits over teeth releases beneficialagents from a reservoir); 5,339,832 (composite mouthguard with integralshock-absorbing framework); 5,365,624 (mouthpieces with cleaning motorsor gum cushioning material); and 6,012,919 (occlusal protector pad in anathlete's dental appliance has an upper layer of EVA andpolycaprolactone).

[0017] Certain hydrogels, particularly synthetic hydrogels, can act ascarriers for drugs and other active agents. These hydrogels allowpassage of the agent, in some cases acting as a membrane that allowsagent passage. Covalently crosslinked hydrogels can incorporate a drugor other agent during the polymerization step; or the agent can beloaded from a solution. These types of hydrogels tend, however, to beweak when swollen by its water content. With thermoplastic (solventsoluble) hydrogels, an agent or drug can be compounded with the polymerduring extrusion or injection molding; or by combining the agent withthe polymer solution in a suitable solvent. See “Hypan® Hydrogels”published by Hymedix International, Inc. The Hypan® hydrogels can beobtained with varying degrees of hydrophilicity. They can also beobtained either as relatively hard, crystalline blocks, used forstructural applications; or as meltable transient clusters that arehighly swelling, and useful as emulsifiers, gelling agents, and drugcarriers. Various other suppliers of hydrogel exist as well.

[0018] For hydrogels with improved stability, see U.S. Pat. No.5,346,935. See also U.S. Pat. Nos. 5,071,657 (transdermal administrationof a medicinal agent dissolved in a nonflowable gel distributed in amicrodisperse mode in a crosslinked silicone elastomer); 5,200,194 (oralosmotic device has a beneficial agent and hydrophilic support fibersinside a semi-permeable membrane); and 5,252,692 (hydrophilic acryliccopolymers).

[0019] See also, U.S. Pat. Nos. 3,996,934 (bandage using microcapsulesto deliver a drug); 5,366,935; 5,286,490 (transdermal patch deliversfluoride medication to treat osteoporosis or periodontal disease); and5,925,372 (transdermal delivery system for ethanol soluble drugs).

[0020] Thus, while prior art devices are capable of delivering an agentto surfaces within the oral cavity, they lack the ability to deliveragents to selected surfaces within the oral cavity, or to deliver one ormore agents to different oral surfaces simultaneously. The presentinvention fulfills this long-felt need by being able to selectivelydeliver agents to specific oral surfaces, and to be able to delivermultiple agents to different surfaces using a single device, whichdevice includes numerous insets for receiving agent-containing insertstherein. This agent delivery function can be performed eitherindependently of, or in conjunction with, the protective functions ofthe present invention, which can also act as an athletic mouthguard.Further, the present invention provides a means to recharge the devicewith an agent once that agent has been depleted.

SUMMARY OF THE INVENTION

[0021] In accordance with the illustrative embodiments demonstratingfeatures and advantages of the present invention, there is provided adental device having a U-shaped carrier with at least one channel forembracing an arch of teeth. The carrier has at least one recessed insetin the at least one channel. The dental device also has at least onediscrete insert carrying a beneficial agent. This insert is adapted tofit into the inset and release the agent gradually.

[0022] In accordance with another aspect of the invention, the foregoingdental device also includes at least one blank removably fitted into theat least one inset.

[0023] In accordance with yet another aspect of the invention, a dentaldevice has a U-shaped carrier with at least one channel for embracing anarch of teeth. The carrier has at least one recessed inset in the atleast one channel. Also included is at least one discrete insert adaptedto fit into the inset. The insert has a different physical character(e.g., softer) than the carrier and is positioned and shaped tomechanically buffer teeth of the arch from mechanical shocks.

[0024] In accordance with still yet another aspect of the invention, adental device that can mechanically buffer an arch of teeth frommechanical shocks has a U-shaped carrier with at least one channel forembracing the arch of teeth. Also included is a beneficial agentsuffused through at least a portion of the carrier. The beneficial agentincludes xylitol or sorbitol in one case, or a remineralizing agent inanother case.

[0025] In accordance with a further aspect of the invention, a method isprovided that employs at least one insert and a U-shaped carrier havingat least one channel with at least one recessed inset containing ablank. The method includes the step of softening at least a portion ofthe carrier along the channel. Another step is pressing an arch of teethinto the channel to make an impression. The method also includes thestep of removing the blank from the at least one inset. Also included isthe step of installing the at least one insert into the at least oneinset.

[0026] In accordance with yet a further aspect of the invention, amethod employs (1) a plurality of inserts suffused with a beneficialagent and (2) a U-shaped carrier having at least one channel with aplurality of recessed insets.

[0027] The method includes the step of installing selected ones of theinserts into less than all of the insets to form a first installedinsert pattern. Another step is removing at least some of the insertsfrom the carrier. The method also includes the step of installing atleast one of the inserts to form a second installed insert pattern.Thus, different oral regions can be affected by different insertpatterns.

[0028] In accordance with still yet a further aspect of the invention, amethod employs a beneficial agent and an athletic mouthguard. The methodincludes the step of suffusing the beneficial agent into the mouthguard.Another step is wearing the mouthguard in an athletic event.

[0029] In accordance with still yet a further aspect of the invention,there is provided a kit for preparing a dental device. The kit includesa dental device with at least one channel for embracing an arch ofteeth. The dental device has a carrier with at least one recessed insetin the at least one channel. Also included is at least one discreteinsert adapted to carry a beneficial agent. The insert is adapted to fitinto the inset and release the agent gradually. Also included is atleast one beneficial agent for incorporation into the at least onediscrete insert.

[0030] In accordance with still yet a further aspect of the invention,there is provided a dental device having a core inside aliquid-permeable shell. The shell has a shape suitable for chewing orteething. The core carries a beneficial agent and is adapted to releasethe agent gradually.

[0031] Methods and devices in accordance with the foregoing canchemically and physically protect a person's teeth and gingiva. An oraldevice (“mouth-guard/carrier”) or method of the foregoing type candirectly apply agents to the teeth and, in one embodiment, provide forthe mechanical protection of the teeth from trauma as a mouthguard. Thismouthguard/carrier preferably contains individual undercut insetsadjacent to each tooth or groups of teeth into which will be placedtherapeutic agents contained in, for example, a hydrogel vehicle asdescribed hereinafter. The number of insets per tooth may vary, rangingfrom one to three (or more) to accommodate the lingual/palatal, buccaland occlusal surfaces. The agent included in a preferred embodiment isthe naturally occurring sugar, xylitol, although other beneficial agentsare contemplated as well; for example, remineralizing agents,moisturizing agents, desensitizing agents, flavoring agents, breathfresheners, chemical and biological indicators, nutraceuticals,antibiotics, probiotics, other medications and chemotherapeutics, etc.

[0032] Two generalized embodiments are described. In one embodiment, thedevice provides an intra-oral device that serves as an athleticmouthguard, provides a novel means of enhanced shock absorption, andcontains insets for agent-containing inserts to be describedhereinafter. In some embodiments disposable inserts, containing agentsto be described presently, are constructed primarily of hydrogels. Theinserts are placed into the device and release the intended agentsdirectly onto the surface of the teeth and/or gingiva. The novel shockabsorption characteristics of the device result from the uniquemechanical force-distributive and dissipating properties of the (e.g.,hydrogel) inserts that are placed in the anterior region (generally fromcanine to canine) which serves an additional function of providing anovel additive cushioning property against mechanical trauma.

[0033] In another embodiment, the steps include providing an intra-oralcarrier made out of standard and typical dental appliance materialsintended solely as a vehicle with insets for holding inserts thatcontain active agents to be described, and for positioning theseproximate to the dentoalveolar tissues. The carrier in this otherembodiment is not necessarily intended to provide mechanical protectionfor the teeth as in the other embodiment.

[0034] Thus the present specification discloses an intra oral devicethat may or may not have mechanically protective features (i.e. functionas a mouthguard, depending on embodiment), may be applied to themaxillary or mandibular arch and will serve to deliver intra-orally,chemicals, therapeutics, medications, pharmaceuticals, nutraceuticals,etc. covered by this application; specifically xylitol and other agentsdisclosed herein as exemplar applications of the agent delivery featuresof the present invention.

[0035] In one embodiment, the carrier material, made of orallyacceptable plastics material, has one or more insets arranged tomaximize mechanical protection of the teeth and surface contact tofacilitate agent delivery. To maintain the shape and retentive integrityof the insets, preferably, blanks will fill the insets and will requireremoval in order to insert the hydrogel inserts. These blanks will beparticularly useful in a “boil and bite,” self-molding carrier ormouthguard.

[0036] It is an object of one embodiment of the present invention toprovide the ability to directly apply, in a timely fashion, agents toprevent and/or reverse the decalcification of teeth, that is potentiatedby the use of a mouthguard, some transient physiologic states, as wellas some medical conditions and/or procedures or medications of a person.

[0037] It is a further object of the invention to provide an improvedmaterial (preferably, hydrogel inserts) that in conjunction with typicalEVA mouthguard materials, or the like, provides enhanced impactabsorbent properties.

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The above brief description as well as other objects, featuresand advantages of the present invention will be more fully appreciatedby reference to the following detailed description of presentlypreferred but nonetheless illustrative embodiments in accordance withthe present invention when taken in conjunction with the accompanyingdrawings, wherein:

[0039]FIG. 1 is a plan view of a dental device showing the open channelof a U-shaped carrier;

[0040]FIG. 2 is a plan view showing the reverse side of the dentaldevice of FIG. 1;

[0041]FIG. 3 is a detailed, cross-sectional view of a blank fitted intoan undercut inset of the dental device of FIG. 1;

[0042]FIG. 4 is a detailed, cross-sectional view of an insert replacingthe blank of FIG. 3;

[0043]FIG. 5 is a detailed, cross-sectional view of an insert that is analternate to that of FIG. 4;

[0044] FIGS. 6A-6D are front views of dental arches showing in phantomfour different arrangements of inserts for devices of the type shown inFIG. 1;

[0045] FIGS. 7A-7E are a cross-sectional views of the device of FIG. 1showing a sequence of steps performed when using that device;

[0046]FIG. 8 is a perspective view of dental device that is analternative to that of FIGS. 1-7 and is useful as a teething device foran infant; and

[0047]FIG. 9 is a cross-sectional view of the device of FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] Referring to FIGS. 1 and 2, a dental device is shown as aU-shaped carrier 10. Carrier 10 has a channel 12 serving as a recess forreceiving an arch of teeth A. In this embodiment the device has only asingle channel 12 for receiving the arch of teeth A, but otherembodiments may have channels on opposite sides for receiving two archesof teeth. The inside wall 12A and outside wall 12B of channel 12 arereferred to as a lingual/palatal surface and buccal/labial surface,respectively. An occlusal/incisal surface 12C is located betweensurfaces 12A and 12B. Surfaces 12A-12C are collectively referred to assurfaces 12.

[0049] A central insert 14A is fitted into an inset in surface 12B, infront of four incisors I and two canines C of arch A (this combinationbeing referred to as the anterior six teeth). A pair of back inserts 14Bare also fitted into an inset in surface 12B, each in front of a pair ofpremolars P. Another pair of back inserts 14C are fitted into an insetin surface 12B, each in front of a pair of molars M (or in some casesall molars). Inserts 14A-14C are collectively referred to as inserts 14.These inserts 14 are placed symmetrically on the buccal surfaces. Theanterior insert 14A extends from canine to canine and laps the incisaledge and extends at least to the cervical junction. The two posteriorinserts 14B and 14C are adjacent to the second premolar through thesecond molar teeth, extending at least to the cervical margins. Thisinsert pattern is intended to act as mouthguard-carrier, but otherpatterns are contemplated, especially for embodiments that are primarilytherapeutic.

[0050] As explained further hereinafter, a greater or lesser number ofinserts may be employed, and these inserts can be designed to cover agreater or lesser number of teeth. Also, this dental device may beinitially shipped without inserts, in which case plastic blanks will beinitially installed in the insets normally containing inserts 14.

[0051] Preferably, and as described further hereinafter, hydrogelinserts will be emplaced within the buccal/labial wall 12B of the EVAplastic of carrier 10.

[0052] The intended material for carrier 10 may, for variousembodiments, be any such material as is currently used in therapeuticdental carriers or sports mouthguards. Mouthguards are typically madefrom plastics materials such as an ethylene vinyl acetate copolymer(EVA). Additives may be added to the EVA itself to provide specialproperties for the mouthguard material. For example, a copolymer ofethylene and about 20% by weight vinyl acetate may be employed. In someembodiments of this device, flavoring and aromatic agents may be addedto the polymer. Colorants, perfumes and softening agents may also beadded as well.

[0053] There are generally three categories: (1) Mouthguards that arestock pre-molded products and made in a variety of sizes. (2) Home orself-moldable to suit the physical characteristics of the user. (3)Custom molded by a dentist or other professional to suit thecharacteristics of the user.

[0054] Typically, custom-made mouthguards are fabricated by avacuum-forming or pressure-forming process whereby two or three laminarsheets of EVA are heat adapted to a mold. The number of lamina used andthe thickness at any point will be determined by the intended use of themouthguard/carrier, i.e. for therapeutics delivery only; or for deliveryof therapeutics while worn as a protective mouthguard in sports relatedactivities.

[0055] The illustrated embodiment is the self-moldable type.Accordingly, the occlusal/incisal surfaces 12C of the carrier 10 containa chemically bonded low-temperature plastic layer 10A that deforms onheating to the temperature of boiling water (approximately 100 degreesCelsius). The user then “bites” into the channel 12 of device 10 andcauses the low-temperature plastic component 10A to mold and conform tothe user's dentoalveolar structures. The portion of the device 10containing the insets intended to bear the hydrogel inserts 14A-14C isnot permanently deformable. (Note relatively stiff blanks may be placedin the insets in the outer wall surface 12B of the EVAmouthguard/carrier 10 when an impression is made.)

[0056] In some embodiments, the carrier need not have separate insertsfitted into recessed insets, since the carrier itself can deliver abeneficial agent. The polymer may contain agents, such as xylitol. Insome embodiments the polymer may contain a remineralizing agent forrestoring calcium in teeth. Several flavors and/or aromas may beavailable to provide a wide selection to the user. The purpose of thisbeneficial agent and additives is to: (1) Provide an incentive for useof the mouth guard. (2) Alert the user when other beneficial agents areexhausted.

[0057] In some embodiments of the present invention, the carrier is notintended to provide mechanical protection as a mouthguard, but isintended solely as an agent delivery system and may be fabricated fromorally acceptable plastics material and having multiple insets. Inembodiments intended for primarily therapeutic application of activeagents, there will be insets not only on the buccal/labial surface 12B,but on the lingual/palatal surface 12A as well (up to 32 for 16 teethper arch, buccal and lingual surfaces). In any event the insets canreceive hydrogel inserts for applying agents to the tissues in thisvicinity.

[0058] Referring to FIG. 3, during the manufacturing of the carrier 10,the shape and integrity of insets 15 are maintained by insert-shapedblanks 18 comprising the same material as the carrier 10. The blanks 18would remain in place during any “boil and bite” type of customizingmolding of stock mouthguard/carriers. The blanks 18 would be removedjust prior to placement of the hydrogel inserts (see FIG. 4).

[0059] In the therapeutic carrier only embodiment, the blanks 18 may beleft in place for certain sites where no therapy is intended. In thiscarrier embodiment, individualized insets 15 may be adjacent to eachtooth or tooth region on the buccal and lingual surfaces for a maximumof 64 insets.

[0060] Referring to FIG. 4, the innermost portion of previouslymentioned surface 12, which is adjacent to the teeth and dentoalveolartissues, will preferably hold preformed standard shaped inserts 14,formed of hydrogel vehicles suffused with intended beneficial agents.The walls of the insets 15 will be undercut to provide for a mechanical“snap-in” lock of the hydrogel material. Insert 14 is shown having abeveled edge 20 to accomplish this snap-in feature.

[0061] Referring to FIG. 5, carrier 10 is shown fitted with an alternateinsert 114. A matrix 122 embedded within insert 114 is in the form of aplastic mesh that enhances the rigidity and structural integrity ofinsert 114. Matrix 122 is shown spaced from the outer surfaces ofinserts 114, but in some embodiments the mesh may be a porous coveringencapsulating the hydrogel carrying the beneficial agent.

[0062] Referring to FIG. 6A, an upper arch A of teeth is shown overlaidin phantom with a carrier 110 similar to previously mentioned carrier10. The teeth of arch A are marked as before. Again, center insert 14Ais shown covering four incisors I and the canines C. In this embodiment,back insert 14B1 has been lengthened from that of FIG. 2 to cover twopremolars P and three molars M. This pattern and the pattern of FIG. 2would be most appropriate for embodiments acting as a mouthguard thatmechanically buffers teeth from mechanical shocks, although nothingwould prevent these embodiments being used primarily for therapeuticpurposes.

[0063] The cervical region of the teeth is that region where the teethnarrow down, or form a neck. This is normally found around cervical lineN. In any event, the cervical region, as that term is used herein, isnot intended to define a mathematically precise domain, but a region inthe neighborhood of cervical line N. Directions extending away from thecervical region N across the crown of the teeth and toward the distalend of the teeth are indicated by direction arrow 16 and are referred toas a occlusal and incisal direction (or extending occlusally andincisally).

[0064] In this embodiment, the purpose of the device is twofold, i.e. toserve as a shock-absorbing mouthguard and therapeutic carrier. There are3 (in some cases 5) insets in the buccal/labial wall of themouthguard/carrier 110 into which is placed agent-containing hydrogels14A and 14B1. The hydrogels serve a second role of shock absorption andcushioning in order to protect the teeth from damaging physical contact.

[0065] Referring to the embodiment of FIG. 6B, the purpose of the deviceis also twofold, i.e. to serve as a mouthguard, but primarily as atherapeutic carrier. There exist approximately 30 insets in thebuccal/labial and lingual/palatal walls of the mouthguard/carrier intowhich are placed agent-containing inserts 14′ made of hydrogels. Theinserts 14′ on opposite sides of the teeth will typically (but notnecessarily) be in registry. The hydrogels will serve a second role ofshock absorption and cushioning in order to protect the teeth fromdamaging physical contact, however, the primary role is to deliveragents to the teeth. The inserts 14′ are each positioned to span acrossa pair of adjacent teeth. For strictly therapeutic purposes, not all ofthe inserts 14′ will be installed but will be placed in a patternappropriate for those teeth needing treatment.

[0066] Referring to the embodiment of FIG. 6C, the purpose of the device10″ is as a therapeutic carrier to bring active agents to theperiodontium, cervical areas and/or interproximal areas of the teeth.There exist one (up to three) insets located at the cervical margins Nof the teeth on the buccal and lingual walls of the carrier 10″ intowhich is placed agent-containing, hydrogel inserts 14″.

[0067] Referring to the embodiment of FIG. 6D, the purpose of the device10′″ is as a therapeutic carrier to bring active agents to theperiodontium, cervical areas and/or interproximal areas of the teeth.There exist approximately 30 insets in the buccal/labial andlingual/palatal walls of the mouthguard/carrier into which are placedagent-containing hydrogels 14′″.

[0068] Referring to FIG. 7A, a cross-sectional view is given ofmouthguard/carrier 10, through a location intended for a centralincisor. The mouthguard 10 is in this embodiment a generic “stock”shape, composed of standard mouthguard material such as an ethylenevinyl acetate copolymer (EVA) substitute or equivalent.

[0069] In addition, there is an EVA blank 18 in the mouthguard/carrier'sinset 15 intended to maintain the integrity of shape of the inset duringa “boil and bite” heating process, to resist deformation. The boil andbite feature is provided herein by the moldable layer 10A′ formed onsurface 12A of carrier 10. Layer 10A′ is chemically bonded to the EVA asa separate, low-temperature material attached to surfaces apart from theinset and strategically placed to conform to the dentoalveolar processand teeth of the user when the material is heated and the user “bites”into the mouthguard/carrier.

[0070] As shown in FIG. 7B, a user now “bites” into device 10 to make animpression on moldable layer 10A′. Significantly, blank 18 provides afirm surface for teeth such as incisor 1, so that a reliable impressioncan be made.

[0071] Referring to FIG. 7C, after the molding process, the EVA blank 18is removed, but moldable layer 10A′ maintains an impression of theteeth. As shown in FIG. 7D, blank 18 will be replaced at an appropriatetime with the agent-containing hydrogel insert 14.

[0072] Referring to FIG. 7E, in use, the hydrogel 14 is in contact withthe labial surface of the incisor 1, as well as other teeth. Thehydrogel 14 releases, over time and in appropriate quantities, theactive agent. In addition, the hydrogel's mechanical properties enhancethe shock-absorbing properties of the carrier 10 as a mouthguard.

[0073] For embodiments having as their main purpose preventing and/orreversing cariogenic activity, inserts 14 will apply agents such asxylitol directly to the teeth. This beneficial agent allows the use ofdevice 10 as a mouthguard, which would otherwise act to acceleratedecalcification by shielding the teeth from the natural cleansingactivity of the lips, cheeks and tongue and buffering action of thesaliva. In addition, the vehicle intended to bring the active agents tothe teeth (hydrogels 14) have unique physical properties that would beadjunctive in the dissipation of potentially harmful kinetic energydirected at the teeth.

[0074] An advantage of the hydrogel delivery system of agents such asxylitol is that the hydrogel acts as a diffusion barrier that allows theagents to be released over a period of hours. Efficacious drug levelsare achieved near the device surfaces, but the agents dilute out quicklyinto body fluids as they move away from the device. Only extremely lowsystemic levels of the agents result because of the dilution.

[0075] The preferred vehicle for agent delivery is a commerciallyavailable hydrogel, such as Hypan® hydrogel from Hymedix International,Inc., Dayton, N.J. This hydrogel is reported to be a hydrophilicacrylate derivative, with each polymer chain having several sequences ofunits with pendant hydrophilic groups (called soft blocks) and severalsequences of pendant nitrile groups (referred to as hard blocks). Thelengths of the blocks, and/or the nature of the side groups, as well asthe overall hydrophilicity of the polymer, are varied depending uponproduction conditions.

[0076] Other hydrogels and agent-releasing vehicles from various sourcesand suppliers are contemplated for other embodiments. The preferredvehicles will be able to contain, and slowly release at a biocompatiblerate and concentration, chemicals known to promote dental health andenamel and dentinal recalcification, such as: (1) Complex of calciumcasein peptone derived from milk (CPP) and amorphous calcium phosphate(ACP), or CPP-ACP. (2) Xylitol. (3) Fluoride containing compounds, suchas: (a) Sodium Fluoride; (b) Stannous Fluoride.

[0077] Other hydrogel materials which are contemplated by the presentinvention include compounds such as polyhydroxy ethyl methacrylate,chemically or physically crosslinked polyacrylamide, polyvinyl alcohols,poly(N-vinyl pyrolidone), polyethylene oxide, and hydrolyzedpolyacrylonitrile. Polysaccharide-based hydrogels, such as covalent orchemically crosslinked polyvalent metal salts of alginates, pectines,carboxymethylcellulose, heparin and hyaluronic acid, as well ashydrogels containing chitin, chitosan, gellan, pullulan, and xanthan arealso contemplated by the present invention.

[0078] Other fluoride containing compounds that may be suitable for usewith the present invention include inorganic fluoride salts such assoluble alkali metals; alkaline earth metals; and heavy metal salts, forexample, potassium fluoride, ammonium fluoride; cuprous fluoride; zincfluoride; stannic fluoride; barium fluoride; sodium fluorosilicate;ammonium fluorosilicate; sodium fluorozirconate; aluminum mono- anddifluorophosphate, fluorinated sodium calcium pyrophosphate and sodiummonofluorophosphate. Calcium fluoride; cobalt ammonium fluoride; zincammonium fluoride; and stannous ammonium fluoride can also be used. Thenknown amine fluorides are also suitable organic fluorides which arecontemplated by the present invention.

[0079] Also, the remineralizing or recalcifying agents envisioned hereinmay be various calcium salts such as calcium phosphate. A commerciallyavailable remineralizing agent is sold as Recaldent™, although otherremineralizing agents are contemplated. Other agents such as fluoridecontaining chemicals (e.g. stannous fluoride, sodium fluoride), xylitolmay be used in combination. The chemical will be activated by saliva andreleased from the hydrogel material at a rate that will be non-toxic.

[0080] Examples of remineralizing agents include calcium compounds suchas: amorphous calcium phosphate; amorphous calcium phosphate fluoride;amorphous calcium carbonate phosphate fluoride, amorphous calciumcarbonate phosphate; potassium oxalate. Other compounds from whichcalcium ions may be obtained include calcium chlorides; calcium nitrate;calcium acetate; calcium benzoate; calcium butyrate; calcium gluconate;calcium formate; calcium fumarate; calcium glycerophophoshate; calciumlactate; calcium isobutyrate; calcium malate; calcium maleate; calciumproprionate and calcium valerate, and mixtures thereof.

[0081] Source of inorganic phosphorus for use in a remineralizingcomposition include mono- and dibasic calcium phosphate; dipotassiumphosphate; monosodium phosphate; sodium metaphosphate; and alkali saltsand ammonium salts of orthophosphoric acid, such as sodium, potassium orammonium orthophosphate.

[0082] A water soluble salt, such as monobasic calcium orthophosphate,can also be used, as a source of both calcium and phosphate ions for useas a remineralizing agent.

[0083] The preferred vehicles will also be able to contain and graduallyrelease agents suitable for treating periodontal disease, such aschlorhexidine, or various antibiotics. Chlorhexidine is most commonlyused in the digluconate form, although other chlorhexidine containingcompounds can be employed. Tetracycline, doxycycline, oxytetracycline,chloramphenicol, penicillin, amoxicillin, erythromycin, streptomycin,sulfonamides, aminoglycosides, cephalosporins, quinolones, are among theantibiotics which can be employed in the present invention. Neomycin,kanamycin, amikacin, tobramycin and gentamycin are among theaminoglycoside antibiotics which can be used. Additional compounds caninclude antiviral agents, such as acyclovir or zidovudine; or antifungalagents, such as imidazoles or polyene antibiotics. Antibacterial agentssuch as benzethonium chloride, benzalkonium chloride, cetylpyridiniumchloride, or dequalinium chloride are also contemplated. The preferredvehicles will also be able to appropriately deliver intraoraldeodorants; and agents for improving the aesthetic appearance of teeth(whiteners), e.g., peroxide containing and peroxide generatingcompounds. It is also desirable to use a device that can flavor thecarrier and therapeutic elements so as to provide an incentive to usethe mouth guard, and alert the user that the protective elements areexhausted and may need to be replaced or recharged.

[0084] The present invention contemplates inclusion of sweeteners andflavorings known to those skilled in the art. These agents can beselected from among those in the following list, which is intended forexamples only, and not intended as any limitation:

[0085] Sugar alcohols such as xylitol, sorbitol, mannitol, and mixturesthereof;

[0086] Water-soluble sweeteners, including monosaccharides,disaccharides and polysaccharides, such as xylose, ribose, glucose,mannose, galactose, fructose, sucrose, maltose, glycerine and partiallyhydrolyzed starch or corn syrup;

[0087] Artificial sweeteners such as aspartyl-phenylalanine methylester, acesulfame K, saccharin and sodium cyclamates.

[0088] As stated above, xylitol is a preferred sweetener because of itsknown non-cariogenic actions; sorbitol may also be substituted therefor.

[0089] The flavorings contemplated by the present invention include bothnatural and artificial flavors, and mint flavors such as spearmint andpeppermint. Flavors such as wintergreen, anise and cinnamon are alsoincluded. Fruit flavors, including citrus flavors like orange, lemon andtangerine and other flavors, either individually or in blends thereof,are also included. These flavorings are generally utilized inconcentrations that depend upon the individual flavor, and may range,for example only, in concentrations of approximately 0.05% toapproximately 6% by weight of the final composition.

[0090] In addition, colorants may added to the compositions. Among thecolorants are pigments which may comprise up to about 2% by weight ofthe composition. These colorants can include what are known to thoseskilled in the art as “FD & C” and “D&C” dyes, meaning dyes suitable foruse in food, drug and cosmetic applications. It is preferred that thedyes utilized be water-soluble. Some examples include a triphenylmethanedye, FD&C Green #3, or a yellow dye designated D&C Yellow #10. TheKirk-Othmer Encyclopedia of Chemical Technology, 3^(rd) edition, volume6, pages 361-495 contains a comprehensive listing of FD&C colorantswhich may be useful in conjunction with the present invention, includingtheir chemical structures, and whose contents are hereby incorporated byreference herein.

[0091] In an embodiment of this device intended to serve as a mouthguardalso, the hydrogel insert will be an integral component of themouthguard and provide a mechanical barrier/cushion contributing to thecushioning and energy dissipative properties of the mouth guard. Thehydrogel will have sufficient integrity of form to maintain its overallshape and to mechanically lock into the receptacle in the mouthguard.The integrity of form may be an intrinsic property of the hydrogel ormay result from an encasement or framework that provides the necessaryintegrity of shape, yet allows an adequate diffusion of agent from thehydrogel. Indeed, the encasement may be desirable in order to controlthe rate of diffusion of the active agent.

[0092] In any event, following the instructions for use, the device andthe hydrogel vehicle will deliver preferably not more than 1 5 grams ofxylitol per 24 hours. At this rate of drug delivery, xylitol is fairlysafe.

[0093] It is appreciated that various modifications may be implementedwith respect to the above described, preferred embodiment. For example,the present invention may be distributed in the form of a kit,containing the dental device, one or more inserts, and a quantity of atleast one beneficial agent which can then be incorporated into theinsert of the dental device.

[0094] Referring to FIGS. 8 and 9, the illustrated dental device 20functions as an infant's teething device, although chewing by adultusers are contemplated for some embodiments. While this device is shownas a ring or toroid, in other embodiments it may be shaped as a disk, arod, or have various other shapes. In some embodiments the teethingdevice may have a handle. In this embodiment the illustrated teethingring 20 has a toroidal core 22 made of a hydrogel as described above ora similar substance.

[0095] Core 22 may be contained inside a liquid-permeable shell, shownin this embodiment as a plastic skin 24 that is perforated by amultiplicity of orifices 26. These orifices may be arranged with adensity of 10 to 1,000 orifices per square inch (1.6 to 160 orifices persquare centimeter), although other embodiments may have a differentdensity depending upon the desired permeability, skin strength, etc. Thethickness of the skin 24 will vary with the strength of the skin'splastic material, balanced against the weakening effect of the orifices26. The skin should be thick enough to avoid rupture, but thin enough toallow adequate diffusion of the active agents contained in the hydrogelcore 22. For example, with a skin made of an EVA polymer, a skinthickness of 0.5 mm to 2.0 mm will operate satisfactorily, although inother embodiments the thickness may be outside this range. Furthermore,the distribution of orifices need not be uniform and may be more denselyspaced in regions where the infant's gums or teeth engage the skin 24.The orifices 26 may be formed with a roller (not shown) having a largenumber of small piercing pins. The sheet of plastic skin, beforeinstallation, may pass over this roller, or the roller may be rolledover the plastic skin.

[0096] The skin 24 may be formed from an upper half 24A and a lower half24B joined along an outer seam 26 and an inner seam 28. These seams maybe welded by heat sealing, by gluing, or by other fastening means. Also,some embodiments may have just an inner seam 28, in which case the skin24 will be one continuous piece with only one seam. Alternatively, theskin can be formed from more than two pieces. In some embodiments, theskin may be formed by spiral wrapping the skin around the toroidalshape. Instill other embodiments, the skin may be molded in place eitheras a perforated surface or a continuous surface that is laterperforated.

[0097] Core 22 is encased in an optional scrim 30, which will be aporous matrix such as a knit or woven fabric. Alternatively, scrim 30may be a fibrous matrix that is readily penetrated by liquid, or arelatively impermeable sheet that is perforated by a number of holes toact as a permeable matrix.

[0098] In use, the infant may chew on the teething ring 20 in the usualfashion. The core 22 will be deformed and the active agent containedtherein will tend to diffuse through the orifices 26. The core 22 can besuffused or impregnated with any one of the beneficial agents mentionedabove, or any combination thereof. Also, in the instance of an infant'steething device, the beneficial agents may include substancesappropriate for soothing the infant's gums. Such agents may be numbingagents or analgesics typically used to soothe the gums.

[0099] Obviously, many modifications and variations of the presentinvention are possible in light of the above teachings. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced otherwise than as specifically described.

1. A dental device comprising: a U-shaped carrier having at least onechannel for embracing an arch of teeth, said carrier having at least onerecessed inset in said at least one channel; and at least one discreteinsert carrying a beneficial agent, said insert being adapted to fitinto said inset and release said agent gradually.
 2. A dental deviceaccording to claim 1 wherein said carrier has in the at least onechannel at least three insets.
 3. A dental device according to claim 1wherein said insert has a beveled edge and said inset is undercut tolock onto said beveled edge and hold said insert in position.
 4. Adental device according to claim 1 wherein said insert is positioned toextend occlusally and incisally from around a cervical region on thearch.
 5. A dental device according to claim 4 wherein said insert ispositioned to extend primarily over one or more dental crowns in orderto protect the teeth from mechanical shocks.
 6. A dental deviceaccording to claim 4 wherein said insert is positioned to extend overone or more cervical regions for periodontal, cervical, andinterproximal treatment.
 7. A dental device according to claim 1 whereinsaid channel has a buccal/labial surface an d a lingual/palatal surface,said insert being located on the buccal/labial surface.
 8. A dentaldevice according to claim 1 wherein said insert provides mechanicalprotection for the anterior six teeth of the arch.
 9. A dental deviceaccording to claim 1 wherein said at least one insert comprises: acentral insert providing mechanical protection for the anterior sixteeth of the arch; and a spaced pair of back inserts providingmechanical protection for premolars of the arch.
 10. A dental deviceaccording to claim 1 wherein said at least one insert comprises: aplurality of inserts each positioned between a different correspondingpair of adjacent teeth of the arch, the inserts each extending coronallyfrom a cervical region.
 11. A dental device according to claim 1 whereinsaid insert comprises a hydrogel suffused with said beneficial agent.12. A dental device according to claim 11 wherein said insert comprisesa supporting matrix for mechanically supporting said hydrogel.
 13. Adental device according to claim 12 wherein said matrix comprises aplastic mesh.
 14. A dental device according to claim 1 wherein saidcarrier comprises a moldable layer that softens at a temperaturesuitable for making an impression by pressing the teeth of the arch intothe channel.
 15. A dental device according to claim 14 wherein saidchannel has a buccal/labial surface and a lingual/palatal surface, saidmoldable layer being located on the lingual/palatal surface.
 16. Adental device according to claim 15 wherein said channel has anocclusal/incisal surface between the buccal/labial surface and thelingual/palatal surface, said moldable layer extending to saidocclusal/incisal surface.
 17. A dental device according to claim 1wherein said beneficial agent comprises xylitol.
 18. A dental deviceaccording to claim 1 wherein said beneficial agent comprises aremineralizing agent.
 19. A dental device according to claim 1 whereinsaid beneficial agent comprises calcium casein peptone.
 20. A dentaldevice according to claim 1 wherein said beneficial agent comprises anantibiotic.
 21. A dental device according to claim 1 wherein saidbeneficial agent comprises a moisturizing agent.
 22. A dental deviceaccording to claim 1 wherein said beneficial agent comprises adesensitizing agent.
 23. A dental device according to claim 1 whereinsaid beneficial agent, comprises a flavoring agent.
 24. A dental deviceaccording to claim 1 wherein said beneficial agent comprises a breathfreshening agent.
 25. A dental device according to claim 1 wherein saidbeneficial agent comprises one or more chemical and biologicalindicators.
 26. A dental device according to claim 1 wherein saidbeneficial agent comprises a nutraceutical agent.
 27. A dental deviceaccording to claim 1 wherein said beneficial agent comprises aprobiotic.
 28. A dental device according to claim 1 wherein saidbeneficial agent comprises a chemotherapeutic agent.
 29. A dental deviceaccording to claim 1 wherein said beneficial agent comprises a fluoridecontaining compound.
 30. A dental device according to claim 1 whereinsaid beneficial agent comprises a chlorhexidine gluconate compound. 31.A dental device according to claim 1 wherein said beneficial agentcomprises tetracycline.
 32. A dental device according to claim 1 whereinsaid beneficial agent comprises a peroxide containing compound.
 33. Adental device according to claim 1 wherein said beneficial agentcomprises one or more agents selected from the group consisting ofchlorhexidine gluconate, tetracycline, oil of clove, one or moreperoxide containing compounds, calcium casein peptone, one or moreantibiotics, a desensitizing agent, a flavoring agent, a breathfreshening agent, a moisturizing agent, xylitol, one or more chemicaland biological indicators, a nutraceutical agent, a probiotic, achemotherapeutic agent, and one or more fluoride containing compounds.34. A dental device according to claim 1 comprising: at least one blankadapted to fit into said at least one inset, said blank being removablefrom said inset in order to permit installation of said insert.
 35. Adental device comprising: a U-shaped carrier having at least one channelfor embracing an arch of teeth, said carrier having at least onerecessed inset in said at least one channel; at least one blankremovably fitted into said at least one inset; and at least one discreteinsert carrying a beneficial agent, said insert being adapted to fitinto said inset and release said agent gradually after removal of saidblank.
 36. A dental device comprising: a U-shaped carrier having atleast one channel for embracing an arch of teeth, said carrier having atleast one recessed inset in said at least one channel; and at least onediscrete insert adapted to fit into said inset, said insert being of adifferent physical character than said carrier and being positioned andshaped to mechanically buffer teeth of the arch from mechanical shocks.37. A dental device for mechanically buffering an arch of teeth frommechanical shocks, comprising: a U-shaped carrier having at least onechannel for embracing the arch of teeth; and a beneficial agent suffusedthrough at least a portion of said carrier, said beneficial agentincluding xylitol.
 38. A dental device for mechanically buffering anarch of teeth from mechanical shocks, comprising: a U-shaped carrierhaving at least one channel for embracing the arch of teeth; and abeneficial agent suffused through at least a portion of said carrier,said beneficial agent including a remineralizing agent.
 39. A methodemploying at least one insert and a U-shaped carrier having at least onechannel with at least one recessed inset containing a blank, comprisingthe steps of: softening at least a portion of the carrier along saidchannel; pressing an arch of teeth into said channel to make animpression; removing said blank from said at least one inset; andinstalling said at least one insert into said at least one inset.
 40. Amethod according to claim 39 comprising the step of: suffusing abeneficial agent into said insert.
 41. A method according to claim 40comprising the step of: replacing said insert in order to refresh thebeneficial agent.
 42. A method according to claim 40 comprising the stepof: removing said insert; refreshing the beneficial agent in the insert;and reinstalling said insert.
 43. A method employing a plurality ofinserts suffused with a beneficial agent and a U-shaped carrier havingat least one channel with a plurality of recessed insets, comprising thesteps of: installing selected ones of said inserts into less than all ofsaid insets to form a first installed insert pattern; removing at leastsome of said inserts from said carrier; and installing at least one ofsaid inserts to form a second installed insert pattern, so thatdifferent oral regions can be affected by different insert patterns. 44.A method according to claim 43 wherein one or more of the inserts insaid first and said second installed pattern have different beneficialagents.
 45. A method according to claim 44 wherein said beneficial agentcomprises one or more agents selected from the group consisting ofchlorhexidine gluconate, tetracycline, oil of clove, one or moreperoxide containing compounds, calcium casein peptone, one or moreantibiotics, a desensitizing agent, a flavoring agent, a breathfreshening agent, a moisturizing agent, xylitol, one or more chemicaland biological indicators, a nutraceutical agent, a probiotic, achemotherapeutic agent, and one or more fluoride containing compounds.46. A method according to claim 43 wherein the beneficial agent used inthe first installed pattern is consistent throughout the first installedpattern but not consistent with the beneficial agent used in the secondinstalled pattern.
 47. A method employing a beneficial agent andathletic mouthguard, comprising the steps of: suffusing the beneficialagent into the mouthguard; and wearing the mouthguard in an athleticevent.
 48. A method according to claim 47 comprising the step of:recharging the mouthguard with the beneficial agent after the athleticevent.
 49. A method according to claim 47 wherein the step of suffusingthe beneficial agent is performed by suffusing the mouthguard with aremineralizing agent.
 50. A method according to claim 47 wherein thestep of suffusing the beneficial agent is performed by suffusing themouthguard with xylitol.
 51. A kit for preparing a dental device; thekit comprising: a dental device having at least one channel forembracing an arch of teeth, said dental device having a carrier with atleast one recessed inset in said at least one channel; at least onediscrete insert adapted to carry a beneficial agent, said insert beingadapted to fit into said inset and release said agent gradually; and atleast one beneficial agent for incorporation into said at least onediscrete insert.
 52. The kit according to claim 51, wherein saidbeneficial agent comprises one or more agents selected from the groupconsisting of chlorhexidine gluconate, tetracycline, oil of clove, oneor more peroxide containing compounds, calcium casein peptone, one ormore antibiotics, a desensitizing agent, a flavoring agent, a breathfreshening agent, a moisturizing agent, xylitol, one or more chemicaland biological indicators, a nutraceutical agent, a probiotic, achemotherapeutic agent, and one or more fluoride containing compounds.53. The kit according to claim 52, wherein the preferred beneficialagent is xylitol.
 54. A dental device comprising: a liquid-permeableshell having a shape suitable for chewing or teething; and a core insidesaid shell carrying a beneficial agent, said core being adapted torelease said agent gradually.
 55. A dental device according to claim 54wherein said core comprises a hydrogel suffused with said beneficialagent.
 56. A dental device according to claim 55 wherein said corecomprises a matrix encompassing said hydrogel.
 57. A dental deviceaccording to claim 56 wherein said matrix comprises a plastic mesh. 58.A dental device according to claim 54 wherein said shell comprises aplastic skin with a multiplicity of orifices.
 59. A dental deviceaccording to claim 54 wherein said device is toroidally shaped.
 60. Adental device according to claim 54 wherein said beneficial agentcomprises xylitol.
 61. A dental device according to claim 54 whereinsaid beneficial agent comprises calcium casein peptone.
 62. A dentaldevice according to claim 54 wherein said beneficial agent comprises anantibiotic.
 63. A dental device according to claim 54 wherein saidbeneficial agent comprises a moisturizing agent.
 64. A dental deviceaccording to claim 54 wherein said beneficial agent comprises adesensitizing agent.
 65. A dental device according to claim 54 whereinsaid beneficial agent, comprises a flavoring agent.
 66. A dental deviceaccording to claim 54 wherein said beneficial agent comprises a breathfreshening agent.
 67. A dental device according to claim 54 wherein saidbeneficial agent comprises one or more chemical and biologicalindicators.
 68. A dental device according to claim 54 wherein saidbeneficial agent comprises a nutraceutical agent.
 69. A dental deviceaccording to claim 54 wherein said beneficial agent comprises aprobiotic.
 70. A dental device according to claim 54 wherein saidbeneficial agent comprises a chemotherapeutic agent.
 71. A dental deviceaccording to claim 54 wherein said beneficial agent comprises a fluoridecontaining compound.
 72. A dental device according to claim 54 whereinsaid beneficial agent comprises a chlorhexidine gluconate compound. 73.A dental device according to claim 54 wherein said beneficial agentcomprises tetracycline.
 74. A dental device according to claim 54wherein said beneficial agent comprises a peroxide containing compound.75. A dental device according to claim 54 wherein said beneficial agentcomprises one or more agents selected from the group consisting ofchlorhexidine gluconate, tetracycline, oil of clove, one or moreperoxide containing compounds, calcium casein peptone, one or moreantibiotics, a desensitizing agent, a flavoring agent, a breathfreshening agent, a moisturizing agent, xylitol, one or more chemicaland biological indicators, a nutraceutical agent, a probiotic, achemotherapeutic agent, and one or more fluoride containing compounds.